UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027350 |
|---|---|
| Receipt number | R000031327 |
| Scientific Title | A prospective study of amino acid profile index for colorectal cancer screening. |
| Date of disclosure of the study information | 2017/05/22 |
| Last modified on | 2017/05/26 19:20:00 |
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Basic information
Public title
A prospective study of amino acid profile index for colorectal cancer screening.
Acronym
A prospective study of amino index colorectal cancer screening
Scientific Title
A prospective study of amino acid profile index for colorectal cancer screening.
Scientific Title:Acronym
A prospective study of amino index colorectal cancer screening
Region
| Japan |
Condition
Condition
early colorectal neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare performance of amino index cancer screening test with fecal immunochemical test for detection of early colorectal neoplasm.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity of AICS for colorectal adenoma, intramucosal cancer and submucosal invasive cancer
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
amino index cancer screening test and fecal immunochemical test
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients who have
1)colorectal adenoma >= 20 mm
2)colorectal intramucosal cancer
3)colorectal submucosal invasive cancer
Key exclusion criteria
Patients
1) with inflammatory bowel disease
2) with familial adenomatous polyposis
3) have multiple primary neoplasms
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahisa Matsuda |
Organization
National Cancer Center Hospital
Division name
Endoscopy division
Zip code
Address
5-1-1,tsukiji,chuo-ku,Tokyo
TEL
03-3542-2511
tamatsud@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Takamaru |
Organization
National Cancer Center Hospital
Division name
Endoscopy division
Zip code
Address
5-1-1,tsukiji,chuo-ku,Tokyo
TEL
03-3542-2511
Homepage URL
htakamar@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Institute for Inovation, Ajinomoto Co
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 15 | Day |
Last modified on
| 2017 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031327
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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